MAUDE Adverse Event Report: DEPUY MITEK LLC US ARTHRO GRASPER PEN 35 UP *EA; SUTURE/NEEDLE PASSER, REUSABLE

Model Number	214601
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: according with the information provided, it was reported that during a shoulder arthroscopy the penetrating grasper 35° up is not closing.The complaint device was received and evaluated.Visual inspection revealed that the device is in normal usage condition.When performing the functional test, it was not possible to open or close the jaws due to a jamming condition.Therefore this complaint can be confirmed.The possible root cause for the reported condition can be attributed to to the age and the constant use of the device that wears away it's internal parts.Since this device is reusable, the metal begins to lose it's shape due to the continuous use causing wear of internal components.However this cannot be conclusively determined.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Udi:(b)(4).
Event or Problem Description
It was reported by the sales rep via phone that during a shoulder arthroscopy the penetrating grasper 35° up is not closing.Another device was used to complete the procedure.No patient consequences or surgical delay reported.The device is available to be returned for evaluation.The lot number is unknown.

• Common Device Name: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10667775
• Report Number: 1221934-2020-02961
• Device Sequence Number: 14366463
• Product Code: NBH
• UDI-Device Identifier: 10886705003846
• UDI-Public: 10886705003846
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 214601
• Device Catalogue Number: 214601
• Device Lot Number: 07K6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 10/12/2020
• Patient Sequence Number: 1